BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LIFESTENT FLEXSTAR XL BILIARY STENT

    MDR report key: 1225281 · Received November 4, 2008

    Report

    Report Number
    9681442-2008-00167
    Event Type
    Malfunction
    Date Received
    November 4, 2008
    Date of Event
    October 4, 2008
    Report Date
    October 6, 2008
    Manufacturer
    ANGIOMED GMBH & CO.
    Product Code
    FGE
    PMA / PMN Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SF
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THIS REPORT IS BEING SUBMITTED, AS THIS PRODUCT IS THE SAME OR SIMILAR TO A PRODUCT 510(K) 060487 CURRENTLY DISTRIBUTED TO THE U.S. THE INVESTIGATION IS CURRENTLY UNDERWAY.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE SURGEON REQUIRED THE STENT TO TREAT A LESION IN THE FEMORAL/ILIAC REGION. THE STENT WAS OPENED AS REQUESTED AND INSERTED USING THE CORRECT STERILE TECHNIQUES AND PROCEDURES. STENT WAS DEPLOYED AND IT WAS NOTED THAT THE STENT LOOKED VERY SHORT FOR THE LENGTH THAT WAS CHOSEN. THE SURGEON THEN INSERTED A 9MM X 40MM PTA BALLOON TO POST DILATE THE STENT. UPON INSERTING THE PTA BALLOON WITHIN THE EXPANDED STENT, IT WAS DISCOVERED THAT THE STENT MEASURED THE EXACT LENGTH OF THE BALLOON. IN DOUBLE CHECKING THE PACKAGING AS WELL AS THE STENT DEPLOYMENT MECHANISM, THEY BOTH STATED 10MM X 80MM. THE STENT WAS IN FACT A 10MM X 40MM WITH THE INCORRECT MARKINGS AND PACKAGING. THE LESION WAS TREATED SUCCESSFULLY, BUT THE FACT THAT THE STENT WAS NOT MARKED OR PACKED CORRECTLY COULD HAVE RESULTED IN AN UNSUCCESSFUL ATTEMPT TO TREAT THE LESION, WITH MAJOR COMPLICATIONS TO THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 LIFESTENT FLEXSTAR XL BILIARY STENT FGE ANGIOMED GMBH & CO. 58334181

    Patients

    Seq Age Sex Outcome Treatment
    1